Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study With a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women With Type 2 Diabetes Mellitus
1 other identifier
interventional
226
7 countries
40
Brief Summary
The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Apr 2008
Typical duration for phase_4 diabetes-mellitus-type-2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2008
CompletedFirst Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2010
CompletedResults Posted
Study results publicly available
March 7, 2011
CompletedApril 18, 2018
March 1, 2018
2.4 years
May 15, 2008
January 7, 2011
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52
FN BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.
Baseline and Week 52
Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days
FN BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Baseline and Week 76+10 days
Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days
FN BMD (measured in grams per centimeters squared \[g/cm\^2\]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Week 52+10 days and Week 76+10 days
Secondary Outcomes (19)
Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52
Baseline and Week 52
Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days
Week 52 + 10 days and Week 76 + 10 days
Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days
Week 52 + 30 days and Week 76 + 30 days
Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76
Baseline, Week 52, and Week 76
Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76
Week 52 and Week 76
- +14 more secondary outcomes
Other Outcomes (2)
Percent Change in Percentage of Free Estradiol From Week 52 to Week 76
Week 52 and Week 76
Percent Change in Free Estradiol From Week 52 to Week 76
Week 52 and Week 76
Study Arms (2)
Arm 1 Treatment A
ACTIVE COMPARATORrosiglitazone up to 8mg/day
Arm 2 Treatment B
ACTIVE COMPARATORmetformin up to 2000mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Female, \>55 to \<80 years
- \>5 years menopausal
- Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
- Drug-naïve (HbA1c \< or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (\< or = 1000mg Metformin), sulfonylureas (\< or = 5mg Glyburide, \< or = 10mg Glipizide or \< or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c \< or = 8.5%); OR Prior monotherapy, \> submaximal doses of metformin (\>1000mg) or sulfonylureas (\>5mg Glyburide, \>10mg Glipizide or \>8mg glimepiride) (HbA1c \< or = 7.0%)
- Weighs \<300 lbs (136.4 kg)
- Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
- Absolute BMD value consistent with T-score \>-2.5 at femoral neck, lumbar spine and total hip
You may not qualify if:
- Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
- Renal or hepatic disease (clinically significant)
- Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
- Recent (\<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
- Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
- Systolic BP \>160mmHg or diastolic BP \>90mmHg while on antihypertensive
- Hypersensitivity to TZDs, biguanides
- Prior treatment with two or more oral anti-diabetic (OAD) agents
- Bilateral hip replacements
- Concurrent diseases affecting bone metabolism
- Active malabsorption syndrome
- Serum calcium outside the central lab reference range
- Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
- Vitamin D deficiency
- Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Huntington Park, California, 90255, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
Torrance, California, 90502, United States
GSK Investigational Site
Vista, California, 92081, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Slidell, Louisiana, 70461, United States
GSK Investigational Site
Las Vegas, Nevada, 89117, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
East Syracuse, New York, 13057, United States
GSK Investigational Site
Kingston, New York, 12401, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Columbia, South Carolina, 29204, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
San Antonio, Texas, 78221, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, B1704ETD, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina
GSK Investigational Site
Buenos Aires, 1425, Argentina
GSK Investigational Site
Buenos Aires, C1128AAF, Argentina
GSK Investigational Site
Vancouver, British Columbia, V6H 3X8, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Granby, Quebec, J2G 8Z9, Canada
GSK Investigational Site
Tallinn, 13415, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Cuernavaca, Morelos, 62250, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64460, Mexico
GSK Investigational Site
Mérida, Yucatán, 97129, Mexico
GSK Investigational Site
Durango, 34000, Mexico
GSK Investigational Site
Lahore, 54000, Pakistan
GSK Investigational Site
Manila, 01008, Philippines
GSK Investigational Site
Marikina City, 1810, Philippines
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Benidorm/Alicante, 03503, Spain
GSK Investigational Site
Granada, 18003, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Petrel, 03610, Spain
Related Publications (4)
Fitzpatrick LA, Bilezikian JP, Wooddell M, Paul G, Kolatkar NS, Nino AJ, Miller CG, Bogado CE, Arnaud CD, Cobitz AR. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics. J Drug Assess. 2011 Dec 16;1(1):11-9. doi: 10.3109/21556660.2011.641703. eCollection 2012.
PMID: 27536422BACKGROUNDGnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PMID: 32501595DERIVEDMiller CG, Bogado CC, Nino AJ, Northcutt AR, Yu HJ, Lewiecki EM, Paul G, Cobitz AR, Wooddell MJ, Bilezikian JP, Fitzpatrick LA. Evaluation of Quantitative Computed Tomography Cortical Hip Quadrant in a Clinical Trial With Rosiglitazone: A Potential New Study Endpoint. J Clin Densitom. 2016 Oct;19(4):485-491. doi: 10.1016/j.jocd.2016.02.003. Epub 2016 Mar 24.
PMID: 27052635DERIVEDBilezikian JP, Josse RG, Eastell R, Lewiecki EM, Miller CG, Wooddell M, Northcutt AR, Kravitz BG, Paul G, Cobitz AR, Nino AJ, Fitzpatrick LA. Rosiglitazone decreases bone mineral density and increases bone turnover in postmenopausal women with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 Apr;98(4):1519-28. doi: 10.1210/jc.2012-4018. Epub 2013 Feb 28.
PMID: 23450056DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 19, 2008
Study Start
April 21, 2008
Primary Completion
September 16, 2010
Study Completion
September 16, 2010
Last Updated
April 18, 2018
Results First Posted
March 7, 2011
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.